Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet, information on the immediate packaging in a foreign language!
Broncho-Vaxom (Broncho-Vaxom for Adults)
7 mg, hard capsules
For use in adults
Active substance: lyophilized bacterial lysates
Broncho-Vaxom and Broncho-Vaxom for Adults are different trade names of the same medicinal product written in Polish and Bulgarian languages.
Please read carefully the information in this leaflet before taking the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Broncho-Vaxom is and what it is used for
- Important information before taking Broncho-Vaxom
- How to take Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the pack and other information
1. What Broncho-Vaxom is and what it is used for
Broncho-Vaxom is an immunostimulant medicine. It contains bacterial lysates from the most common bacteria causing respiratory tract infections.
In humans, the medicine stimulates cellular and humoral immune mechanisms by activating macrophages, increasing the number of circulating T lymphocytes, and enhancing the concentration of immunoglobulins secreted by the respiratory mucosa.
The indications for use of Broncho-Vaxom are:
- Prevention of recurrent respiratory tract infections (RTIs) in adults.
2. Important information before using Broncho-Vaxom
When not to use Broncho-Vaxom
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Broncho-Vaxom, consult your doctor or pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment should be discontinued immediately and the doctor should be informed.
The use of Broncho-Vaxom for the prevention of pneumonia is not recommended, as there are no clinical study data confirming such an effect.
Use in elderly patients
In clinical studies of Broncho-Vaxom, elderly populations were widely represented. No safety concerns were identified.
Renal impairment
Data on use in patients with impaired renal function are limited. In preclinical toxicity studies, no relevant signs of nephrotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Hepatic impairment
There are no available data on use in patients with impaired liver function. In preclinical toxicity studies, no relevant signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Interaction of Broncho-Vaxom with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
To date, no interactions between Broncho-Vaxom and other medicines have been reported.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Available data on the use of Broncho-Vaxom in pregnant women are limited. Animal studies have not shown any direct or indirect harmful effects on reproduction.
As a precautionary measure, the use of Broncho-Vaxom during pregnancy is not recommended.
Breastfeeding
No studies have been conducted to evaluate the use of this medicine in breastfeeding women. As a precautionary measure, the use of Broncho-Vaxom during breastfeeding is not recommended.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Broncho-Vaxom contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, meaning the medicine is considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Broncho-Vaxom is intended for oral use in adults.
Recommended dose:
Prophylactic treatment cycle in cases of recurrent respiratory tract infections:
One hard capsule (7 mg for adults) once daily on an empty stomach, for 10 consecutive days per month,
over 3 consecutive months.
During acute phases of respiratory tract infections, the medicinal product may be used
concurrently with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
For oral use.
If the patient cannot swallow the capsule, it may be opened and its contents mixed with an appropriate amount of water, fruit juice, or milk.
The mixture disperses with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be stirred immediately before consumption.
Taking more Broncho-Vaxom than recommended
Contact a doctor.
If you forget to take Broncho-Vaxom
Do not take a double dose to make up for the missed capsule. Take the next dose at the usual time.
Stopping Broncho-Vaxom
Do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been observed:
Common (may occur in up to 1 in 10 patients):
Headache, cough, diarrhoea, abdominal pain, rash.
Uncommon (may occur in up to 1 in 100 patients):
Nausea, vomiting, urticaria, fever, fatigue.
Allergic reactions, including: red skin rash, rash affecting the whole body, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles or legs (peripheral oedema), swelling, facial swelling, itching, including itching of the entire body, shortness of breath.
Frequency unknown (frequency cannot be estimated from the available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema).
In case of skin reactions and disorders of the respiratory system, or gastrointestinal disturbances, treatment with Broncho-Vaxom should be discontinued and medical advice sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. How to store the medicine Broncho-Vaxom
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.
6. Contents of the packaging and other information
What Broncho-Vaxom contains
The active substance is OM-85 lyophilisate 40 mg,
containing lyophilised bacterial lysates:
Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae,
Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus
aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella
(Branhamella/Neisseria) catarrhalis 7 mg.
Other components of the medicine are: propyl gallate (E 310), monosodium glutamate (E 621), mannitol,
pregelatinised starch, magnesium stearate.
Capsule shell composition: gelatin, indigo carmine (E 132), titanium dioxide (E 171).
What the Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom capsules are opaque, with a blue body and blue cap.
Packaging: 10 hard capsules (1 blister of 10 units, in a cardboard box).
Packaging: 30 hard capsules (3 blisters of 10 units each, in a cardboard box).
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Bulgaria, country of export:
Omedicamed Unipessoal Lda
Avenida António Augusto de Aguiar n° 19-4°
1050-012 Lisbon
Portugal
Manufacturer:
Flavine Pharma France
3 voie d’Allemagne
13127 Vitrolles
France
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland
Marketing authorisation number in Bulgaria, country of export: 20030171
Parallel import authorisation number: 159/25